As Project Manager, Regulatory Affairs, you are responsible for providing guidance to Regulatory staff to support global regulatory submissions and regulatory strategies and for managing essential regulatory department projects. You are also responsible for the development, maintenance, review and enhancement of documentation, training, auditing, and compliance and also provide technical guidance to regulatory affairs staff and cross-functional teams.
- Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations.
- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Manage, review, and approve global submissions
- Maintaining departmental performance metrics
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes, customs requests, and deviations to ensure compliance with FDA and international government regulations.
- Work with consultants to manage all submissions for a particular country or countries.
- Review and approve distribution and consulting agreements.
- Maintain compliance of distribution control database
- Maintain the company's medical device listing and device & tissue establishment registrations
- Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
- Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities.
- Write, revise, and approve internal standard operating procedures (SOP’s)
- Participate in new-hire employee selection process
- Mentor new hires as requested by management
- Review and approve surgeon evaluation and prototype devices
- Project and budget management
- Ensure that internal training programs, policies and procedures are implemented and continuely evaluated and updated to maintain compliance with current regulatory and industry standards
- Direct management of regulatory affairs consultants, and projects by setting performance standards and overseeing project management, progress, and timely completion.
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
- Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence
- Ability to respond to inquiries and complaints from customers and regulatory agencies
- Ability to effectively present information to other employees, management, and regulatory agencies
- Ability to work well in a cross-functional setting and lead cross-functional teams assigned to individual projects
- Responsible for implementing global regulatory strategy.
- Responsible for ensuring that domestic and international submissions are filed in accordance with all appropriate regulations and product launch timelines.
- Responsible for managing regulatory projects.
Bachelor's Degree in engineering, life sciences, or equivalent technical field required (Master's Degree preferred)
- Minimum 5 years' experience in the regulatory field in a regulated industry
- Experience with medical devices, orthopedics preferred
- Extensive knowledge of FDA and applicable international regulations and standards required
- Experience with planning and preparing complex regulatory submissions for global filings to include, but not limited to the US (i.e., PMA, IDE, 510(k)) Europe and Japan
- Cross-functional teamwork experience
- Professional certification desirable